BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3021535 · Received March 26, 2013

    Report

    Report Number
    2024168-2013-01730
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE: BALANCE MIDDLEWEIGHT: GUIDE CATH: 6FR, STENT: ION (2), XIENCE V. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF RESTENOSIS, AS LISTED IN THE ELECTRONIC XIENCE V / XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE NC TREK REFERENCED AND ADDITIONAL XIENCE STENT REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT RESTENOSIS OF XIENCE V STENTS (MORE THAN 1), DEPLOYED IN THE RIGHT CORONARY ARTERY DURING A PREVIOUS PROCEDURE IN ANOTHER HOSPITAL. TWO NON-ABBOTT STENTS WERE DEPLOYED SUCCESSFULLY TO TREAT THE RESTENOSIS AND THE 4.0X20 MM NC TREK WAS USED TO PERFORM POSTDILATATION OF THE TWO STENTS. AFTER FULL DEFLATION OF THE BALLOON, WITH NO DIFFICULTIES EXPERIENCED DURING DEFLATION, RESISTANCE WAS FELT DURING RETRACTION OF THE BALLOON CATHETER FROM THE DEPLOYED STENTS. THE BALLOON WAS REINFLATED AND DEFLATED SEVERAL TIMES; HOWEVER, THE BALLOON COULD NOT BE RETRACTED. NEGATIVE PRESSURE WAS APPLIED AGAIN AND THE BALLOON WAS ABLE TO BE RETRIEVED TO THE TIP OF THE 6FR GUIDING CATHETER, BUT COULD STILL NOT BE RETRACTED INTO THE GUIDE. INFLATION AND DEFLATION OF THE BALLOON WAS PERFORMED AGAIN, AND THIS TIME THE BALLOON CATHETER WAS ABLE TO BE RETRACTED FROM THE PATIENT. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124723 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R